Clinical Research Imaging Systems and Tips

July 7, 2015

Clinical research imaging has become an important tool in documenting a product or treatments performance in clinical trials.  It can serve as another line of evidence to support claims and study data, and is useful in communicating results from the study, especially when combined with image analysis.   Many of our clients have given us compliments on the quality of our images and we would like to share our top 10 tips on how to produce high quality images that can be helpful if you are taking them in-house or what to look for when qualifying a site for a study.

The overall key is to success in any imaging workflow is to maintain tight control over the imaging system and procedures.

  1. Choose the right camera and set up based on the goals of the study. There are many different options for imaging systems.  The more well-known one in the clinical research area are the Canfield Systems, but there are many other options, such as custom setups like the Stephens Imaging System or the Hirox KH-1300, that JRC just acquired, which is useful to capture up close images of pores and dry skin.  At Stephens, we provide a wide variety of imaging systems for our clients to accommodate any needs they may have.  If we don’t own it, then we look into renting it.
  2. Select the right lighting conditions. The most common options in the research area are macro, visible light, cross-polarized light, raking light, UV reflectance, and UV fluorescence and which one to use depends upon the study objectives. For example, if a sponsor wished to highlight the texture on a panelist’s cheek, then we would recommend a raking light design where the cheek is illuminated at a grazing angle. The sharp angle of light causes the texture on the cheek to cast small shadows, emphasizing wrinkles, acne scars, or other desired features.  Each piece of equipment varies on the lighting options available as well.
  3. Maintain consistent color and exposure by using a color checker.
  4. Note taking and documentation! Document the lighting and camera settings, positioning notes, and other crucial data to ensure consistency during the project accurate reproduction at a later date. Refer to the standards throughout the study.  It’s critical to document exposure control, white balance, evenness of illumination, depth of field, and lens selection.
  5. Ensure the position of the subject is consistent from visit to visit. This is by far the most challenging element to control.  At Stephens, we use software that allows us to overlay a live video of the panelist over a baseline photograph to help us position the panelist as they were in their baseline visit.  We also set up our cameras and rigs to minimize the amount a panelist has to move.
  6. Capture images as RAW files and re-save as JPEGs. The RAW files will allow you to do analysis on the images and JPEGs are quicker and easier to view on a computer.
  7. Quality Equipment! Make sure the equipment is in good condition and kept calibrated, when needed.
  8. Training of staff on how to use the equipment.
  9. Have written procedures (SOPs) and Work Instructions that detail the operations, processes and practices that should be followed to make sure everyone is aligned.
  10. Finally, communication! From a site stand point, we need to know what your expectations are and how you plan on using these photos.  From there, we can help make sure we select the right piece of equipment, lighting condition, set up and delivery method.

We believe that this attention to detail allows us to produce consistent images from the first visit to the last and gives us an air of professionalism that our clients have come to admire.  Please contact us to learn more about imaging for clinical trials and our imaging options.

Stephens Subject Database and Recruiting for Clinical Trials

July 7, 2015

We often get questions about our subject database and how we recruit for our clinical trials.  We put together a list to help answer these questions!

 

  1. What methods do you use?

We use a variety of channels but the most effective is word of mouth and referral.  We find that the key is to get our name out there consistently to create an awareness so we can recruit difficult eligibility requirements.  The effectiveness of each also depends upon the location.

  • Word of mouth
  • Facebook in US
  • Mixi in Japan
  • Twitter
  • Email
  • Current Database
  • Google +
  • Craigslist
  • Local blogs
  • Local magazines
  • Community Engagement Events
  • TV
  • Radio
  • Newspapers
  • Festivals

Our Japanese Research Center has a recruiting center in Ikebukuro, Tokyo, one of the most populated districts in Tokyo.

  1. How large is your database?

The numbers are approximate and are subject to change.

Dallas: 25,000

Colorado Springs: 10,500

Tokyo: 3,000

We also partner with a research site in Seoul, SK that has 10,000 subjects in their database.

 

  1. What is the demographic profile of your database?

This is always changing as we get studies that require different eligibility requirements. It also differs at each location but this gives a general overview.

Gender

Males: ~25%

Females: ~75%

Ethnicity/Race

Our subjects come from a variety of ethnic backgrounds and race, which include Caucasian/white, African American/black, Asian, Hispanic or Latino, American Indian and Mixed/Other.

Ages

3 months to 84 years old with a majority falling in the 26-55 age categories.

What conditions do they have?

Subjects in our database have a variety of conditions and below are the more common ones

  • Normal Healthy Volunteers
  • Sensitive skin
  • Dry, oily, and combination skin
  • Skin problems such as acne, pigmentation issues, melasma, rosacea, eczema, psoriasis, keratosis, hyper and mottled pigmentation, cellulite
  • Variety of aging skin conditions and levels of severity. For example photodamage, wrinkles/lines, melasma, uneven skin tone, lack of radiance and clarity, sagging skin, etc.
  • Herpes
  • Hair Loss
  • Nail Fungus
  • Diaper rash
  • Hypertension
  • Seasonal allergies
  • Hormone imbalance
  1. How long does it take to recruit for the study?

It depends upon the eligibility criteria, but we make every effort to get it done as quickly as possible.  We know you have deadlines to meet!  We do block enrollment and bring groups of subjects in at one time.  This is more efficient compared to a doctor’s office, which typically enrolls 1-2 subjects at a time.

We also have an online registration process in which allows us to keep track of their contact information, demographics, what conditions they have and studies they qualified for.

Please contact us with any other questions that we might have missed.

Stephens Clinical Research Imaging System

July 7, 2015

Stephens has redesigned our imaging system to produce higher quality and more consistent images for your clinical trials.  With the new imaging system, the panelist remains still and the camera rotates around a track.  Therefore, throughout the series of photographs, the panelist does not need to be re-positioned.

See how Stephens Imaging System matches up against the industry standard, VISIA CR by Canfield.

Stephens Imaging System

Contact us to use it for your study and see sample images of this amazing photostation.

Visioscan® VC 98

March 27, 2015

Stephens has acquired the Visioscan® VC 98 from Courage-Khazaka which is a high resolution UVA-light video camera. The images show the structure of the skin and the level of dryness very impressively, but it can also be used on spots or hair and scalp.

Visioscan® VC 98 from Courage-Khazaka

Visioscan® VC 98

 

 

 

 

 

 

Contact us to use this for claim support and see our complete list of study equipment.

Laser Doppler Monitor moorVMS-LDF

March 27, 2015

Stephens has acquired the moorVMS-LDF laser Doppler blood flow and temperature monitor which is a high performance, medical grade module for clinical skin assessments. Use of DSP technology brings uncompromised specification, quality and reliability.

See the Moor website for a complete list of the features!

Contact us to use this to assess the performance of your product and see our complete list of study equipment!

ICI 9320 Infrared Camera

March 27, 2015

Stephens acquired the InfraRed Camera 9320P series from ICI which is a thermal imaging camera which measures and demonstrates skin surface temperature.

Contact us to use this in your study and see our complete list of study equipment.

Change in Staff in Stephens’ Office of Asian Studies

March 27, 2015

Ritsuko Cardona, Stephens’ Supervisor of Asian studies, has moved to Tokyo to be closer with her family. Starting April, she will be assuming the position of Site Manager of the Japan Research Center (JRC) working directly for Nobuko Naoi, the Site Director of JRC, instead of Stephens.  In her new role, she will be assisting Nobuko with managing JRC, clinical grading, marketing and training staff on clinic procedures and GCPs.  We are happy that she will continue to help Stephens as a Client Liaison to assess study feasibility and to provide study quotes and study dates to clients and schedule client visits.  We believe that this will speed up the process of finalizing quotes and scheduling and sending study dates to clients.

Ayumi Ohara, who has been working in Stephens’ Asian Office since 2011 as Senior Clinical Scientist, has been appointed the new Supervisor of Asian Studies.  Ayumi will take over communication with clients after the study has been placed.  Rico and Ayumi have been training together for the past 3 months to make this a smooth transition.  We are expecting that the transition will be complete by May.

Please join us in wishing both Ritsuko Cardona and Ayumi Ohara success in their new roles.
Ayumi and Rico’s contact information can be found here.

Using Image Analysis for the Detection and Evaluation of Wrinkles

June 11, 2014

Typically photographs taken during a clinical study are used to document visible changes in skin conditions and for marketing purposes.  By using Stephens’ image analysis, which can detect and quantify changes in an objective manner, you can maximize the use of your images by collecting additional data from them.

Our wrinkle image analysis, SWIRL (Stephens Wrinkle Imaging using Raking Light), will provide you with the number, length, area and depth of the wrinkles on multiple facial areas.

SWIRL

SWIRL on Crow’s Feet Area

We provide image analysis on any clinical photographs, whether they are taken at one of our sites or at a different site.  The key is to have high quality images with the correct lighting mode.  We are happy to assist you to determine the correct lighting mode and answer any questions on how to obtain high quality images for the analysis.

At the most recent ISBS meeting in Connecticut, Dr. Lily Jiang presented Stephens’ poster entitled “Quantitative analysis of multiple photoaging features using image analysis of digital photographs” and won best poster!  SWIRL was also published in the June 2013 issue of the peer-reviewed journal, Skin Research and Technology.

Stephens also provides image analysis for a variety of other skin parameters.  A full listing is located here.

Maximize the use of your images and contact Dr. Lily Jiang to use Stephens’ image analysis and to learn more about our image analysis services.

 

New Stephens Site Manager

June 10, 2014

Stephens is excited to introduce you to our newest employee and Site Manager at Colorado Research Center (CRC) Kun “Mark” Qian, MD, MS, BRAMS.

Mark received his Doctor of Medicine from Shanghai Second Medical University in 1995, Master of Science in Molecular Biology/Pediatrics in 1998, Foreign Medical Graduate Certification (ECFMG) US in 1995, and Master of Science, Biomedical Regulatory Affairs from the University of Washington, School of Pharmacy, Seattle, WA.

He served as a Research Scientist at the University of Washington for several years and later as a consultant.  He has a thorough understanding of FDA regulations, ICH guidelines and a solid knowledge of conducting and monitoring clinical trials.

As the Site Manager and Investigator, Mark will assist clients with their testing needs and be their primary contact, oversee the operation of CRC, and perform visual evaluations.

Contact Dr. Qian by email or at 719-637-2828 ext. 332 to discuss how Stephens can help you with your testing needs and to “meet him”.

Stephens Advances Capabilities for Silicone Replica Analysis

June 4, 2013

To better assist you with your projects, we have recently made advancements in our silicone replica image analysis capabilities.  Analysis parameters have been expanded and we now offer analysis of silicone replicas for studies placed outside of Stephens.

We will photograph replicas, and process and analyze the digital images for the parameters you have selected using a macro developed by Stephens using Image Pro Plus v7 software and in accordance with the Guidelines for Evaluation of Cosmetic Functions published by the Japanese Cosmetic Science Society (JCSS).  Then we will interpret the results and provide you with a report.  The results in the report can be presented in any format you prefer and we can generate a surface plot.  We will send you a copy of the images, data and report on  a DVD for your records.  If you prefer a different storage device, please let us know and we can accommodate your request.

Available Parameters:

Fine and Coarse Wrinkle Parameters

  • Number
  • Spacing
  • Area Covered
  • Total Depth
  • Maximum Depth

Skin Roughness Parameters

  • IDL
  • Ra
  • Rz

To get started with replica analysis, simply contact us and we will take care of the rest.

Silicone Replica impression

Photograph of silicone replica impression

Surface Plot

Surface Plot

More...